Contact information
Type
Scientific
Primary contact
Prof Atif Rahman
ORCID ID
Contact details
Child & Adolescent Psychiatry
School of Population
Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5509
atif.rahman@liverpool.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Integration and evaluation of a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan: a cluster randomised controlled trial
Acronym
PROBE Study
Study hypothesis
The aim of this project is to provide the National Program for Family Planning and Primary Health Care of Pakistan and their Lady Health Workers (community health workers) with a well-researched, evidence-based intervention to promote exclusive breastfeeding, which has the potential for up-scaling. The objective of the project is to integrate a community-based exclusive breastfeeding promotion intervention into the routine work of Lady Health Workers, train them in using this approach, and to evaluate its effect on rates of exclusive breastfeeding.
Hypotheses:
Compared to mothers receiving standard breastfeeding advice by Lady Health Workers, mothers who receive the experimental intervention (also by Lady Health Workers) will:
1. Have a higher rate of exclusive breastfeeding (defined as giving maternal milk at the only infant food source in the previous week, with no other liquids or food given) at 6 months post-natally
2. Have a longer duration of exclusive breastfeeding
3. Have reduced levels of psychosocial distress
Ethics approval
Human Development Research Foundation, registered with the Office of Human Research Protections (OHRP), gave approval on the 10th December 2008 (ref: HDRF/IRB/002)
Study design
Cluster randomised single-blind parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breastfeeding
Intervention
The proposed study is a cluster randomised controlled trial with two parallel arms. The intervention arm will receive seven sessions of this maternal focused approach to promote breastfeeding through Lady Health Workers. The control arm will receive a similar number of visits of routine counselling for breastfeeding through different Lady Health Workers.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
All assessments will be carried out using instruments that have been translated, field-tested and validated in the local population through our previous work. Assessments will be carried out at baseline (third trimester), and prospectively for 6 months after birth.
Baseline measures:
1. Socioeconomic status (household income and assets)
2. Maternal age
3. Education
4. Body mass index
5. Scores of psychosocial distress on the Self-Reporting Questionnaire (SRQ)
6. Number of children
7. Family structure
8. Levels of post-traumatic stress and depressive reactions to the 2005 earthquake in the study area, assessed using the Earthquake Exposure Scale
Main outcome:
The duration of exclusive breastfeeding (EBF) and its rate at 6 months, measured prospectively using the following method: each mother enrolled into the study will be visited fortnightly by an independent team, blind to the allocation status of the mother, to record the breastfeeding status and practice in the last 24 hours. For this study, EBF was defined as: only breastfeeding being practiced with no other semi-solid or liquid foods (other than medication and/or oral rehydration solutions).
Secondary outcome measures
1. Psychological distress, measured at baseline, 3 and 6 months using the Self-Reporting Questionnaire (SRQ-20). This psychiatric screening instrument, which was developed specifically for use in primary care by health workers in developing countries, has 20 items with a 'yes' or 'no' response to questions about psychological and somatic symptoms in the past 30 days.
2. Rates and duration of predominant and partial breastfeeding, assessed at 6 months of infant's age prospectively using the above mentioned method
3. Process outcomes: studied qualitatively using key-informant interview and focus groups. At the 'system' level, the opinion of key personnel from the programme and primary health care (including LHWs), will be obtained on all aspects of training, delivery, usefulness and potential costs of the intervention (in terms of extra time and material needed to deliver the intervention). At the family level, we will obtain feedback from mothers and other significant family members about the intervention.
Overall trial start date
01/05/2009
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Married, consenting women
2. Aged 17 - 40 years
3. Pregnant; in their 3rd trimester of pegnancy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
440 third trimester pregnant women
Participant exclusion criteria
1. A diagnosed medical or mental illness
2. Currently under treatment, e.g., tuberculosis, hepatitis B or C or a mental health illness
Recruitment start date
01/05/2009
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Pakistan
Trial participating centre
Child & Adolescent Psychiatry
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
c/o Prof. Atif Rahman
Child and Adolescent Psychiatry
School of Population
Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Mulbery House
Eaton Road
Liverpool
L 12 2AP
United Kingdom
+44 (0)151 252 5509
atif.rahman@liverpool.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
United States Agency for International Development (USAID) (USA) - International Rescue Committee, Inc (IRC-PRIDE)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Liverpool (UK)
Alternative name(s)
Universidad de Liverpool
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary